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Also known as Epinephrine autoinjector single dose, Epinephrine 4mg nasal powder spray
Epinephrine · 1 trial · 1 indication
Severity grading system for acute allergic reactions. Skin system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021
Severity grading system for acute allergic reactions, mucosal system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021
Severity grading system for acute allergic reactions, gastrointestinal system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.
Severity grading system for acute allergic reactions, respiratory system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.
Severity grading system for acute allergic reactions, Combined systems, anaphylaxis score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.
Systolic and diastolic blood pressure by a blood pressure cuff
heart rate by pulse rate measurement
% oxygen saturation measurement using oxygen monitor
| Arm | Type | Description |
|---|---|---|
| FMXIN002 4mg + saline IM | EXPERIMENTAL | Epinephrine powder nasal spray together with a placebo IM injection |
| Adrenaline 0.5mg IM + placebo nasal spray | ACTIVE_COMPARATOR | Epinephrine IM injection together with a placebo nasal spray |
| Name | Type | Description |
|---|---|---|
| Epinephrine 4mg nasal powder spray | COMBINATION_PRODUCT | Epinephrine nasal powder spray in a unidose nasal applicator device. Will be administered together with a placebo saline IM injection |
| Adrenalin 0.5mg Injectable Product | COMBINATION_PRODUCT | Epinephrine 0.5mg for IM injection. Will be administered together with a placebo nasal powder spray. |
Inclusion Criteria: * Age 18-40 years, any gender * Documented or suspected food allergy (based on IgE level or clinical history) * Development of Grade II or III reaction during OFC Exclusion Criteria: * Age \<18 or \>40 * Poorly controlled asthma (FEV1 \< 80% or frequent symptoms) * Active eosi...
Epinephrine is used for the emergency treatment of anaphylaxis caused by food. It is being developed as a nasal powder spray for patients at risk of this severe allergic reaction. The drug is currently in Phase 2 clinical development and is not yet approved for use.
Epinephrine is an agonist that targets multiple adrenergic receptors, including ADRA1A, ADRA2A, ADRB1, ADRB2, ADRA2C, and ADRA1D. By activating these receptors, it works to counteract the severe allergic response associated with anaphylaxis.
Epinephrine is being developed by Nasus Pharma Ltd., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug as a nasal powder spray for the treatment of food-induced anaphylaxis.
Epinephrine is in Phase 2 clinical development. It is an investigational drug being studied for the treatment of anaphylaxis caused by food. The drug has not yet received regulatory approval and is still undergoing clinical trials to assess its safety and efficacy.
Epinephrine is being studied in a Phase 2 clinical trial with the identifier NCT07045701, titled "FMXIN002 in Patients at Risk of Anaphylaxis." This randomized, double-blind, active-controlled trial is enrolling 30 participants in Israel and is currently enrolling by invitation.
Epinephrine is also known as Epinephrine autoinjector single dose and Epinephrine 4mg nasal powder spray. These names refer to the same drug, which is being developed by Nasus Pharma Ltd. for the treatment of food-induced anaphylaxis.